Frequently Asked Questions: Research
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Q: What is tau?
Q: How long does it take to develop a drug?
The first step in drug development is understanding the disease or condition that you want to treat. Initial research in this area will help to identify potential drug targets for the future.
Designing a new drug
Once a target has been found it can take many years to develop a drug from scratch. However, often there are existing drugs that are good candidates. This helps to cut down the time required.
A new drug must go through several rounds of testing before trials in humans can begin. First it is tested in cells grown in a laboratory to check that it will work. Next the drug is tested in an animal model for safety and toxicity, and to see if it has the desired effect. This process takes 3 - 5 years.
Testing a drug in people
Only then can a drug start trials in humans. Clinical trials progress in a stepwise fashion, gradually involving more people. It usually takes 8 - 10 years for a drug to be licensed. Each increasing step is called a 'Phase' and there are four phases:
- Phase I: Checking for side effects and testing the dosage. Usually about 30 people
- Phase II: Does it work in the people with the condition? The drug is tested against a placebo. Usually about 200 people
- Phase III: How effective is it? The drug is tested in hundreds or thousands of people and can then be licensed for medical use.
- Phase IV: How does the drug perform in the long-term? This involves following people over a series of years.
In total, it takes an estimated 10 - 15 years to develop, test and license a new drug.
